Chain Drug Review - Schering-Plough gets okay to sell clarinex for allergies
KENILWORTH, N.J. — Schering-Plough Corp. bas received Food and Drug Administration approval of Clarinex (desloratadine) for the treatment of seasonal allergic rhinitis (SAR).
The product builds upon the company’s heritage as a discoverer and developer of allergy and respiratory products as demonstrated by the success of its Claritin collection of nonsedating antihistamines and by Nasonex, a once-daily nasal steroid for allergies.
Clarinex is designed to provide 24-hour relief of nasal and nonnasal symptoms of seasonal allergies.
Cleared in the form of 5-mg. tablets, the product, known by its generic name of desloratadine, is for use by patients 12 and older.
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The company bas also received an approvable letter from the FDA for Clarinex tablets for the treatment of chronic idiopathic urticaria (CIU) or hives of unknown cause. Separately, a New Drug Application is pending for the treatment of allergic rhinitis that encompasses both SAR and perennial allergic rhinitis.
“We are gearing up for a vigorous launch of Clarinex, with the goal of making this product the nonsedating antihistamine of choice,” declares chairman and chief executive officer Richard Jay Kogan.
Schering-Plough is reportedly prepared to provide Clarinex for two complete allergy seasons before the earliest anticipated launch date for generic versions of Claritin, which is sometime in the fourth quarter.
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